"Clinical Research Coord Senior (Inter underfill)"

The Division of Nephrology is seeking a Clinical Research Coordinator (CRC). This role provides coordination for multiple clinical research studies of varying complexity. Candidates must demonstrate prior experience and proficiency in all CRC-Intermediate responsibilities, including engagement with University committees. Mentoring colleagues in student management and supporting the training and development of junior clinical research professionals. Applying advanced knowledge and critical thinking to solve complex problems across diverse clinical studies. Leading the design, development, and evaluation of new processes, procedures, tools, and training to advance clinical research initiatives. Guiding, training and supporting study team members in implementing research activities. This position requires a commitment to ongoing professional development and continuing education. Key behavioral competencies include designing, developing, evaluating, guiding, mentoring, and supporting.

Underfill Statement: This position may be underfilled at the CRC-Intermediate title based on selected candidates' qualifications and the review and approval of the Michigan Medicine CRC Governance Board.

The posting will fill a Senior CRC position for a funded study beginning in April 2026, lasting five years, and with up to 30 clinical sites (outpatient dialysis centers) nationally. The University of Michigan is the Coordinating Center. The CRC will be responsible for activities at one of the Coordinating Centers hubs, the Clinical Coordinating Center (CCC), housed in the Department of Internal Medicine under the direction of the study's faculty PI. The CRC will ensure that the highest rigor is applied to study performance, including trial conduct, data integrity, and research subject protection. They will work with other team members to develop the protocol and study documents; contribute to processes and tools to support best practices; act as liaisons across study team members; run study meetings; and ensure adherence to the study budget. They will oversee and support the study's clinical sites, with the goal to promote successful recruitment, retention, and study conduct. They will support clinical site activities, including informed consent (obtained electronically), data entry, and data quality. They will support and monitor recruitment, retention, and protocol adherence; and oversee the study's participant engagement activities. Additionally, the CRC may serve as the site coordinator at UM as one of the study's clinical sites.

Central Coordination of Study Operations - 30%

• Ensure that the highest rigor is applied to study performance including trial conduct, data integrity, and research subject protection.
• Work with other team members to develop the protocol, Manual of Procedures, and all participant materials.
• Contribute to the development of processes and tools to support best practices associated with study execution.
• Acts as a point of contact and liaison between the study's investigators, research teams, funder, and other stakeholders to get questions answered and issues resolved.
• Run regular study meetings
• Ensure adherence to study budget in support of the study PI and in collaboration with research administrators.

Central Clinical Coordination of Study Sites - 30%

• Oversee and support the study's 20-30 clinical sites, with the goal to promote successful recruitment, retention, and study conduct.
• Support all start-up, implementation, and closeout activities at clinical sites.
• Support clinical sites as needed with informed consent (obtained electronically), data entry, and data quality.
• Support and monitor recruitment, retention, and protocol adherence.

Stakeholder Engagement - 20%

• Oversee patient/partner engagement across the study team and participating sites.
• Ensure adherence to the funder's Foundational Expectations for Engagement.
• Develop and implement the engagement strategy.
• Coordinate with team leadership on integration of patient and caregiver perspectives, and troubleshoot site-level engagement challenges.

Site-level Study Coordination - 10%

• Serve as lead site coordinator at UM as one of the study's clinical sites, responsible for recruitment of ten or more participants over two years and their retention over the study period.

Oversight of Assisting Coordinator - 10%

• Provide oversight and mentorship of the Assisting Coordinator in accomplishing the Clinical Research Coordinator teams scope of activities.

Contribute to the development of processes and tools in all 8 competency domains is expected:

1. Scientific Concepts and Research Design
2. Ethical Participant Safety Considerations
3. Investigational Products Development and Regulation
4. Clinical Study Operations (GCPs)
5. Study and Site Management
6. Data Management and Informatics
7. Leadership and Professionalism
8. Communication and Teamwork

Supervision Received: This position reports directly to the Faculty Principal Investigator

Supervision Exercised: Could provide Functional supervision and/or administrative supervision of (1) more staff in the role of Clinical Research Assistant, Clinical Research Technician, CRC Associate, and CRC Intermediate

Required Qualifications:

• Bachelor's degree in Health Science or an equivalent combination of related education and experience is necessary.
• Certification is required through ACRP as a Certified Clinical Research Coordinator (CCRC) or SOCRA as a Certified Clinical Research Professionals (CCRP) or equivalent. Candidates must be eligible to register or take the exam at date of hire and the certification must be completed or passed within six months of date of hire.
• Senior: Minimum 5 years of directly related experience in clinical research and clinical trials is necessary.
• Intermediate: Minimum 3 years of directly related experience in clinical research and clinical trials is necessary.

Desirable Qualifications:

• Master's degree in health science or an equivalent combination of related education and related experience is desirable.
• Spanish-Language proficiency is desirable but not required
• Senior: 9+ years of direct related experience
• Intermediate: 6+ years of direct related experience

Must be Flexible. This position can be hybrid with at least 2/3 days/wk. on site work depending on the needs of the study.

The use of this title requires approval by the University of Michigan Clinical Research Coordinator Governance Board to ensure equity in title placement across Michigan Medicine.